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FDA 510(k)

DUAL NEEDLE SUTURE PASSER SYSTEM

K-Number: K082518 · 2009-01-16

ApplicantCayenne Medical, Inc.
Decision Date2009-01-16
Product CodeGAT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DUAL NEEDLE SUTURE PASSER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Cayenne Medical, Inc.. It received FDA 510(k) clearance on 2009-01-16 under 510(k) number K082518. The device is classified under product code GAT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DUAL NEEDLE SUTURE PASSER SYSTEM?

DUAL NEEDLE SUTURE PASSER SYSTEM is a medical device that received FDA 510(k) clearance on 2009-01-16. The listed applicant is Cayenne Medical, Inc.. The 510(k) number is K082518.

When did DUAL NEEDLE SUTURE PASSER SYSTEM receive FDA 510(k) clearance?

DUAL NEEDLE SUTURE PASSER SYSTEM received FDA 510(k) clearance on 2009-01-16, under 510(k) number K082518.

Who is the listed applicant for DUAL NEEDLE SUTURE PASSER SYSTEM?

The FDA 510(k) record lists Cayenne Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DUAL NEEDLE SUTURE PASSER SYSTEM?

The FDA product code for DUAL NEEDLE SUTURE PASSER SYSTEM is GAT.

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Other records listing Cayenne Medical, Inc. as applicant

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Related Devices (Code: GAT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253910Stitch - Suture Wires and TapesGM Dos Reis Industria e Comercio Ltda.K261021EasyWhip FamilyWinter Innovations, Inc.K260775Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™Teleflex Medical, LLCK254275HyperSuture All Green Extension LineThreadstone, LLCK254188Meniscus VersaflexGM Dos Reis Industria e Comercio Ltda.K253145Pre-Sutured TendonRti Surgical, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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